Remdesivir has little effect on Covid-19 mortality: WHO

Gilead calls the findings premature; analysts do not see much impact on Indian makers of the drug

Gilead’s remdesivir has little or no impact on Covid-19 patients’ length of hospital stay, initiation of ventilation, or chances of survival, a clinical trial by the World Health Organization (WHO) has found.

The US biotech giant, however, questioned the findings of the study, saying these were premature and the data appeared inconsistent. Other studies, the firm said, had validated the drug’s benefits.

Listed pharmaceutical companies that manufacture remdesivir in India — Cadila Healthcare, Cipla, and Jubilant Life Sciences — seemed to defy the negative news, as their shares ended the day in the green. Cadila Healthcare’s stock was, in fact, up 3.4 per cent on the BSE. Indian clinicians indicated that they would continue to prescribe the drug. The antiviral medication was one of the drugs used to treat US President Donald Trump’s coronavirus infection.

The results of the WHO’S Solidarity trial, conducted on 11,266 hospitalised

Covid-19 patients across 30 countries, found that remdesivir, along with other repurposed drugs hydroxychloroquine (rheumatoid arthritis drug), lopinavir/ritonavir (used in leprosy), and interferon, “appeared to have little

effect on in-hospital mortality”.

Senior officials in Indian pharma firms that have licensing agreements with Gilead to make and sell remdesivir said they did not expect a major fall in demand for the drug as long as doctors continued to prescribe it.

Analysts, too, said that for big pharma firms like Cipla and Cadila Healthcare, there would not be any major downside on the stock prices. “Remdesivir’s contribution to their top lines is not very significant, and we do not expect doctors to suddenly stop prescribing the drug because one study found it is not very useful,” said Sapna Jhawar, vice president (research), Dolat Capital.

Explaining the clinician’s experience, Satyanaryana Mysore, head of department of interventional pulmonology at Manipal Hospitals, said meta-analysis did not necessarily capture the true essence of a drug’s efficacy or impact on the patient. “As part of the task force of remote medical guidance to hospitals across Karnataka, I have seen the difference the drug made,” he said.

“Prior to July 15, when the drug was not available here, morbidities and the severity of cases in government hospitals were much higher. Remdesivir definitely helped,” he said, adding timing of administering the drug could make a difference. Gilead expressed concern that the data from the open-label global trial had not been under a rigorous review. Open-label trial basically means that participants, as well as the investigators, know which drug is given to them. The Us-based drug major and the innovator of Veklury, or remdesivir, said it was unclear if any “conclusive” findings could be drawn from the study results.

“The emerging data appears inconsistent with more robust evidence from multiple randomised, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury,” the company said.

The company said they were concerned that the data from this trial had not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design. WHO, however, defended the data. "It's a reliable result, don't let anybody tell you otherwise, because they'll try to,” Richard Peto, an independent statistician hired by WHO to scrutinise its Solidarity trial results, said.